AccessGUDID - DEVICE: Serum Control (04250317543998)

GUDID

Device Identifier (DI) Information

Brand Name: Serum Control
Version or Model: 0088
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0088
Company Name: Chromsystems Instruments + Chemicals GmbH

Primary DI Number: 04250317543998
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328712260 *Terms of Use

Device Description: Serum Control Level II, Levetiracetam (Keppra®) in serum/plasma

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55673	Levetiracetam therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug levetiracetam (e.g., Keppra) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	Drug Specific Control Materials

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10 x 2ml

Device Record Status

Public Device Record Key: a71641e6-c91f-4aef-b021-2d74cdab47fd
Public Version Date: August 07, 2020
Public Version Number: 1
DI Record Publish Date: July 30, 2020